Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Brimonidine Tartrate; Brimonidine Tartrate, Timolol Maleate Drug Combination; Dorzolamide; Maleic acid; Timolol

Criteria

Inclusion Criteria:

• Male or female over 18 years

• Female subjects of childbearing potential must have negative pregnancy test and practice contraception

• Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes

• Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate

• Subjects able to complete questionnaires and provide informed consent

Exclusion Criteria:

• Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control

• Subjects wherein the study drugs are contraindicated

• Subjects who have had intraocular surgery with 6 months (3 months for laser)

• Subjects with known side effects/allergy or sensitivity to any component of study treatments

• Subjects with any uncontrolled systemic disease